Richard J. Obiso, Ph.D.
Owner/Clinical Investigator
Richard J. Obiso, PhD dba Avila Herbals, LLC
4025 Childress Road
Christiansburg , VA 24073-5968
United States
(b)(6)FEI 3016760965Issued Feb 4, 2022Center for Drug Evaluation and Research | CDER
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3016760965.
Violations5
Issue DateFeb 4, 2022
Product TypeOther
StatusOpen
Letter Details
Firm
Richard J. Obiso, PhD dba Avila Herbals, LLC
Location
Richard J. Obiso, Ph.D.
Owner/Clinical Investigator
Richard J. Obiso, PhD dba Avila Herbals, LLC
4025 Childress Road
Christiansburg , VA 24073-5968
United States
(b)(6)
FEI Number
3016760965
Country
United States
Issue Date
February 04, 2022
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Other
Status
Open
Summary
Richard J. Obiso, PhD operating as Avila Herbals, LLC, a clinical investigator and sponsor of an investigational drug study, failed to comply with federal regulations governing clinical investigations under 21 CFR 312 and the Federal Food, Drug, and Cosmetic Act. The FDA's inspection from July 12-26, 2021 identified objectionable conditions, including a failure to submit a required Investigational New Drug (IND) application for conducting the clinical investigation. Despite Avila Herbals' written response to the FDA's Form 483 observations in August 2021, the company did not adequately address the violations related to human subject protection and investigational drug conduct requirements.
Richard J. Obiso, PhD dba Avila Herbals, LLC FDA Warning Letter, February 4, 2022
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